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Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

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ClinicalTrials.gov Identifier: NCT02486848
Recruitment Status : Withdrawn
First Posted : July 1, 2015
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Maja Kovacevic, MD, Applied Biology, Inc.

Brief Summary:

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.


Condition or disease Intervention/treatment Phase
Female Pattern Hair Loss Androgenetic Alopecia Drug: 5% Topical Minoxidil Solution Drug: 15% Topical Minoxidil Solution Not Applicable

Detailed Description:

Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil.

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The investigators have developed an in-vitro diagnostic test that correctly identifies, prior to initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a sufficient amount of minoxidil will be converted to the active form required to induce hair growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and a reduced frequency of adverse events.

Consequently, the investigators hypothesize that in subjects with low enzymatic activity (i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic response with little or no increase in the frequency of adverse events. It is thus the primary purpose of this study to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Placebo Comparator: 5% Topical Minoxidil Solution
5% Topical Minoxidil Solution
Drug: 5% Topical Minoxidil Solution
5% Topical Minoxidil Solution

Active Comparator: 15% Topical Minoxidil Solution
15% Topical Minoxidil Solution
Drug: 15% Topical Minoxidil Solution
15% Topical Minoxidil Solution




Primary Outcome Measures :
  1. Target Area Hair Count [ Time Frame: baseline to week 24 ]
    Target Area Hair Count. Number of hairs measured in the target area by macrophotography

  2. Subjects Ratings [ Time Frame: baseline to week 24 ]
    Subjects Ratings


Secondary Outcome Measures :
  1. Target Area Hair Count [ Time Frame: baseline to week 12 ]
    Target Area Hair Count. Number of hairs measured in the target area by macrophotography.

  2. Expert Panel Global Photography Assessment [ Time Frame: baseline to week 24 ]
    Treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females in overall good health
  • Age: 18 to 55
  • Female pattern hair loss (Sinclair 2-4)
  • Willing to have a mini dot tattoo placed in the target area of the scalp
  • Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
  • Able to give informed consent
  • Non-responder to 5% minoxidil as determined by the MX-IVD test i.e., low minoxidil metabolizer
  • Able to comply with the study requirements for 24 consecutive weeks
  • Willing to use an adequate method of birth control (if applicable)
  • Negative urine pregnancy test

Exclusion Criteria:

  • Previous adverse event from topical minoxidil treatment
  • History of hypotension
  • Uncontrolled hypertension
  • Use of any hypertensive drugs
  • Pregnant, nursing, or planning a pregnancy during the study
  • Prior hair transplant
  • Uses wigs or hair weaves
  • Have used minoxidil (topical or oral) anytime during the past 6 months
  • Chronic scalp disorders that require medications
  • Uses medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
  • Folliculitis
  • Scalp psoriasis
  • Seborrheic dermatitis
  • Inflammatory scalp conditions such as lichen planopilaris
  • Enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
  • Responder to 5% minoxidil as determined by the MX-IVD test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486848


Locations
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Italy
Istituto Scienze Dermatologiche
Florence, Tuscany, Italy
Sponsors and Collaborators
Maja Kovacevic, MD
Investigators
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Principal Investigator: Maja Kovacevic, MD University of Rome, Italy ("G. Marconi")
Publications:
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Responsible Party: Maja Kovacevic, MD, Clinical Researcher, Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT02486848    
Other Study ID Numbers: FI-DRUG-MINOXIDIL-001
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Keywords provided by Maja Kovacevic, MD, Applied Biology, Inc.:
Hairloss
Female Pattern Hair Loss
Androgenetic Alopecia
Minoxidil
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Pharmaceutical Solutions
Antihypertensive Agents
Vasodilator Agents